BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MINICAP TRANSFER SET

    MDR report key: 2230752 · Received September 1, 2011

    Report

    Report Number
    1423500-2011-11544
    Event Type
    Malfunction
    Date Received
    September 1, 2011
    Date of Event
    August 1, 2011
    Report Date
    August 15, 2011
    Manufacturer
    BAXTER HEALTHCARE - MOUNTAIN HOME
    Product Code
    KDJ
    PMA / PMN Number
    K882498
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WA, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THIS COMPLAINT COULD NOT BE CONFIRMED IN THE LAB. THE ROOT CAUSE OF THE COMPLAINT CANNOT BE DETERMINED. THE RETURNED SAMPLE RETURNED DID NOT SHOW ANY CONNECTION PROBLEMS. A BATCH REVIEW WAS NOT POSSIBLE SINCE THE LOT NUMBER WAS UNKNOWN. IN THIS CASE THE EVALUATIONS DID NOT FIND ANY EVIDENCE OF ANY PROBLEM. BAXTER WILL CONTINUE TO MONITOR SIMILAR REPORTS TO DETERMINE IF FURTHER ACTIONS ARE REQUIRED.

    Additional Manufacturer Narrative · 1

    (B)(4). A REQUEST FOR THE RETURN OF THE DEVICE HAS BEEN MADE. SHOULD THE DEVICE BE RECEIVED BY BAXTER FOR EVALUATION, A FOLLOW-UP REPORT WILL BE FILED UPON COMPLETION OF AN EVALUATION OR IF ANY ADDITIONAL INFORMATION BECOMES AVAILABLE.

    Description of Event or Problem · 1

    THE HOME PATIENT'S (HP) REGISTERED NURSE (RN) CONTACTED PRODUCT SURVEILLANCE TO REPORT A LOOSE CONNECTION ON THE HP'S TRANSFER SET ON (B)(6) 2011. THE RN STATED THAT THE CAREGIVER (CG) CONTACTED HER ON THURSDAY, (B)(6) 2011, TO REPORT THAT THE NAVY BLUE PORTION ON THE TRANSFER SET (WHERE IT CONNECTS TO THE ADAPTER) HAD COME HALF A TURN LOOSE FROM THE LIGHT BLUE PART OF THE TRANSFER SET. THE CG SAID THAT THEY HAD JUST TWISTED THE PIECE BACK AND THE HP CONTINUED THERAPY. THEY TOLD THE RN ABOUT IT THE NEXT MORNING. THE RN TOLD THE CG TO MONITOR THE HP FOR ANY SIGNS OF INFECTION AND IF THEY SEE ANY SIGNS TO BRING THE HP INTO THE CLINIC. THE RN SAID THAT SHE WOULD CHANGE THE TRANSFER SET OUT ON THE (B)(6) 2011, THE HP'S NEXT APPOINTMENT AND WOULD RETURN THE SET FOR EVALUATION. THE RN STATED THAT SHE TOOK ANOTHER TRANSFER SET THAT SHE HAD AROUND THE CLINIC TO SEE IF SHE COULD REPRODUCE THE SAME OCCURENCE. SHE COULD NOT. THE RN STATED THAT SHE TOOK THE TRANSFER SET APART AND REPORTED THAT THE LOOSE PIECE WAS A FAILURE IN PRODUCT BUT THE STERILE PATHWAY WAS NEVER BREACHED. THERAPY HAS BEEN GOING WELL SINCE INCIDENT. THERE WAS NO PATIENT INJURY OR MEDICAL INTERVENTION INDICATED AT THE TIME OF THE INITIAL REPORT. NO FURTHER INFORMATION AVAILABLE. THERE WAS PATIENT INVOLVEMENT

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 MINICAP TRANSFER SET SET, ADMINISTRATION, FOR PERITONEAL DIALYSIS, DISPOSABLE KDJ BAXTER HEALTHCARE - MOUNTAIN HOME

    Patients

    Seq Age Sex Outcome Treatment
    1 14 YR HOMECHOICE